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510(k) K897134

CMW CEMENT PRESSURISATION SYSTEM by Dentsply Intl. — Product Code KIH

K897134 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "CMW CEMENT PRESSURISATION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 2, 1990. The device falls under product code KIH (Dispenser, Cement), a Class I device regulated under 21 CFR 888.4200. Dentsply Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1990
Date Received
December 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dispenser, Cement
Device Class
Class I
Regulation Number
888.4200
Review Panel
OR
Submission Type

Other clearances by Dentsply Intl.

  • K140347 — ANKYLOS C/X IMPLANT SYSTEM (August 20, 2014)
  • K130862 — CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM (July 23, 2013)
  • K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC (February 22, 2013)
  • K103244 — QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION (February 14, 2011)
  • K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II (October 30, 2009)
  • K083805 — ANKYLOS C/X DENTAL IMPLANT SYSTEM (May 22, 2009)
  • K082198 — DURASHIELD PLUS (October 29, 2008)
  • K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS (March 27, 2008)
  • K072989 — AXIS SYSTEM (January 28, 2008)
  • K073117 — DENTIN DESENSITIZER AGENT (December 19, 2007)

Other clearances for product code KIH

  • K042591 — SMARTMIX PRE-FILLED MIXING SYSTEM (October 22, 2004)
  • K943906 — P.F.C. CEMENT PRESSURIZING SYSTEM (December 21, 1994)
  • K851881 — ORTHOPEADIC CEMENT DELIVERY SYSTEM (June 13, 1985)
  • K840046 — PRESSURIZING/SCAVENGING ACRYLIC CEMENT (February 9, 1984)
  • K833675 — BRIGHAM TIBIAL CEMENT PRESSURIZER (December 12, 1983)
  • K811317 — HOWMEDICA FEMORAL PRESSURING SEAL (May 29, 1981)
  • K801388 — OH-HARRIS (July 28, 1980)
  • K790275 — GUN, EXETER CEMENT (February 21, 1979)
  • K781955 — GUN, CEMENT (December 4, 1978)
  • K780266 — BONE CEMENT APPLICATOR (February 28, 1978)

FDA data resources